Apple Watch Series 11: FDA Clears Hypertension Alerts — What You Need to Know
Apple announced that the Apple Watch Series 11 (and Apple Watch Ultra 3) received FDA clearance for a new hypertension alerts feature. The watches begin shipping on September 19, 2025, and Apple says the feature will be available in 150+ countries.
How the feature works
- The Watch uses its optical heart sensor and a new machine-learning algorithm trained on large datasets (reports cite studies involving 100,000+ participants) to look for patterns associated with high blood pressure over a month-long background monitoring period.
- It does not measure your blood pressure directly. Instead, it notifies users if patterns suggest possible hypertension so they can seek medical follow-up.
Regulatory note
Apple received FDA clearance for this alert — clearance is a regulatory authorization that differs from full FDA approval. The company previously received FDA clearance for features like over-the-counter hearing aid functionality (AirPods Pro) and sleep apnea detection.
Availability & pre-orders
Apple says the feature will be available on Series 11, Ultra 3, and compatible older models with the required watchOS update. The devices ship starting Sept 19, 2025, and pre-orders are available from Apple and major retailers.
Amazon product search links (affiliate tag added):
– Series 11: https://www.amazon.com/s?k=Apple+Watch+Series+11&tag=f1rede-20
– Ultra 3: https://www.amazon.com/s?k=Apple+Watch+Ultra+3&tag=f1rede-20
Sources
- Apple Newsroom: Introducing Apple Watch Ultra 3
- 9to5Mac coverage: Apple Watch hypertension alerts receive FDA clearance
Quick take
This is a meaningful step for passive health monitoring on wrist devices: the alerts could help flag a condition that affects over a billion people. But remember the watch flags potential risk — it is not a replacement for clinical blood pressure measurement.
Question for readers: Would you rely on your watch to alert you to possible hypertension, or would you prefer a cuff-based measurement? Share your thoughts below.
Correction: The feature received FDA clearance, not full FDA approval.